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    PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    SILVERVENT

    FDA UDI
    Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948011012·SILVERVENT 1 ICU, SIZE 4

    Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989025194·PREF ARCH NI-TI UPPER 18 LARGE PK10

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110528·LOCATOR R-Tx Abutment for Narrow Platform (NP) ...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114717·LOCATOR F-Tx Abutment for Narrow Platform (NP) ...

    Humelock II Cemented Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037300190·Humelock II Cemented Shoulder System, 2 PEGS G...

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EMS SWISS DOLORCLAST

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481128684·LOCATOR R-Tx Abutment, Narrow Platform (NP) Tri...

    ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EMS-SWISS DOLORCLAST

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523162789·12mm 30° Angled Awl, Direct

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523162383·Tesera C Inserter Stop, 8mm

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523150502·NSA Cervical Cage Inserter

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148387·NSA Cervical Anatomic Rasp

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148370·Cervical Tamp

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148363·Tesera C Cage Inserter

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523162420·Tesera C Inserter Stop, 12mm

    NI-TI WIRE

    FDA Adverse Event
    Injury ·ORMCO CORPORATION·Product code ECN·June 18, 2015